About this opportunity
Smith & Nephew lists this Director, Regulatory Affairs – AWB opportunity in fort worth, Texas. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Life Unlimited. At Smith+Naphew we design and manufacture technology that takes the limits off living. Reporting to the Senior Vice President Global Regulatory Affairs and Commercial Quality the Director Regulatory Affairs Wound will develop and implement global regulatory strategies in support of business objectives, provide strong leadership to their regulatory team and other cross functional team members.
What will you be doing?
The Director will lead the regulatory strategy for the Advanced Wound Bioactives (AWB) portfolio of products that include Sec 351 regulated Biologic products, Sec 361 regulated Human Cells, Tissues, and Cellular and Tissue- Based products (HCT/P) as well supporting the NPD portfolio of device-led combination products.
Responsible for leading a regulatory team spread across two locations (Fort Worth, TX and Columbia, MD). This includes developing and mentoring the RA department to build an effective and efficient responsive team.
Lead the regulatory team in development of regulatory strategies for 510(k), sBLA and Health Canada submission and approvals.
Participate and support FDA audits/inspections to maintain all necessary certifications/approvals and ensure compliance with applicable regulations.
Champions a culture of collaboration, leadership, mutual accountability, critical thinking and continuous improvement within a high-performing team. Represents Regulatory Affairs with excellence in cross-functional interactions and represent Business RA with excellence in interactions with regional RA representatives.
Responsible for assuring compliance with all relevant laws and regulations, domestic and international.
What will you need to be successful?
Minimum Bachelor's degree in Sciences, Engineering or equivalent.
A minimum of ten years' regulatory experience required.
Proven experience in leading FDA BLA and sBLA CMC submissions and FDA medical device submissions including 510(k)'s and Q-subs.
Experience and knowledge on Sec 361 regulated Human Cells, Tissues, and Cellular and Tissue-Based products (HCT/P) highly desired.
In-depth experience in dealing with FDA and international medical device regulatory agencies.
Expert regulatory knowledge within relevant therapy area (Biologics, HCT/P's and device-led combination products).
Ability to work strategically within complex, business critical and high-profile programs.
Ability to think strategically and critically evaluate risks to regulatory activities.
Must demonstrate strategic thinking with ability to influence, strong initiative, work ethic and excellent oral and written communication skills.
Benefits and Compensation
401k Matching Program
401k Plus Program
Discounted Stock Options
Tuition Reimbursement
Flexible Personal/Vacation Time Off
Paid Holidays
Flex Holidays
Paid Community Service Day
Medical
Dental
Vision
Health Savings Account (Employer Contribution of $500+ annually)
Employee Assistance Program
Parental Leave
Fertility and Adoption Assistance Program
Hybrid Work Model (For most professional roles)
Hands-On, Team-Customized, Mentorship
Discounts on fitness clubs, travel and more!
Smith+Naphew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
Inclusion + Belonging: Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website
Stay connected by joining our Talent Community. We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer. Smith+Naphew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Naphew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.
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Worksite address
fort worth, TX, 76102, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.